Storage and sterilization systems for veterinary and human dental and medical instruments are known in the art. Many devices include features to stack and space. In the art of medical surgical instruments, storage trays for sterilization and storage of instruments are common. However, such systems have limitations. For example, one type of tray, although well adapted for use in a first surgical procedure, is ill suited for a second type of surgical procedure. A general instrument kit, commonly used in many operating room procedures, is not suitably versatile to adapt for use as operating room procedures change, are modified, or are replaced with new procedures.
The term “general instrument kit” refers to a set of devices commonly used in surgery and includes ringed instruments such as snaps, clamps, Kellys, Ailises, Babcocks, Kochers, needle holders, sponge sticks and scissors, among other rigid instruments. Prior to use, a general instrument kit is sterilized and packaged at a location remote from a particular surgery suite. Before a specific surgery or procedure, the requisite sterilized instrument kit(s) are sent to a particular operating room, which is being prepared for that specific procedure. In the operating room a back table is lined with sterile drapes. Then, sterile supplies are removed from their outer packaging and placed on this back table. One surgical nurse does a surgical scrub, puts on a sterile gown and gloves and rearranges the multiple sterile supplies needed for the given procedure—placing them in an arrangement and order—not governed by specific instructions, not standardized, but rather based on that person's experience and preference, which is determined in part on the nature of the surgical procedure and the anticipated sequence of use, probable outcomes, potential error-mitigation efforts, and other criteria.
During this preparation, the ringed instruments are removed from sterile buckets and unstrung from each of two long-armed “stringers.” The buckets include other instruments that are not strung on the stringers, but are, rather, left loose in the bottom of the bucket. These instruments, too, need to be arranged for later use and are placed on the back table. Once all the supplies and instruments are arranged a required complete count of all the instruments and supplies is made.
The lack of standardization causes delays in both the initial preparation of the instruments and, more critically, during surgery, especially when a scrub nurse is commonly relieved during a procedure. The replacement scrub nurse, who did not arrange the instruments, does not have implicit knowledge of the location of each instrument or supply. This is a known limitation to the aforementioned method.
Currently used instrument trays contain grooves or recesses, which are designed for specific, individual instruments. While many of these known trays include additional mechanisms or features configured to hold specific individual instruments in a preferred orientation, they are not optimized to hold a large quantity of varying instruments in an “operation ready” position. Other known trays increase adaptability by providing removable section dividers combined with fixed section dividers. However, this is disadvantageous as the removable dividers must be accounted for and can be dislodged during use. This adds risk by potentially becoming lost inside the patient during surgery, or simply dislodged causing one or more instruments to be disrupted while on the tray, thus delaying the surgical process, for example.
One known device in the art is a multipurpose surgical instrument tray disclosed by Smith in U.S. Pat. No. 6,426,041, and issued on 2002 Jul. 2. One significant limitation of the Smith device, as illustrated best in FIG. 3 of Smith, is that both a portion of the ring-end of a surgical instrument and the “sharp” end of the same instrument rests above, or stands proud, in relation to a first flat top surface of the tray. This enables users to be cut or punctured by the sharp end of the instrument, which is very undesirable. It also leaves the sensitive tips of the medical instruments exposed and subject to damage and degradation, thus requiring replacement often.
Other known devices and techniques include protective tip covers designed to protect the patient and staff from sharps injury with a certain degree of success. However, the success is limited as frequently these sharps protective tips must be carefully examined prior to use and the sharp instrument frequently cuts through the protective tip and wrapper or package. This methodology is limited in that it relies upon visual inspection by a trained, naked eye, and as such is highly variable and prone to human error. Furthermore, presuming all sharp tips are protected, well-inspected, and delivered to the sterile field, and then the protected instruments are properly placed on the Mayo stand and/or back table, the removed sharps protective tips are not tracked once they are removed from the instrument. Thus presents a major disadvantage, as it is known that these discarded protective tips may manage to find a way into the patient; this presents as a foreign object with ensuing poor patient outcomes and resultant adverse legal implications.
Other known art includes U.S. Pat. No. 7,565,972, issued on 2009 Jul. 28, titled “Medical Equipment Tray System” to Steppe. This medical equipment tray system includes three parts: a platform portion, a foldable liner, and a hand-piece cradle. Another known reference includes a “Grooved Angled Tray for Ring-Handled Surgical Instrument,” described in U.S. Pat. No. 7,066,328, issued on 2006 Jun. 72 to Pulsifer.
To date there is no known or proven methodology that adequately protects the patient and the users from sharps injury, while at the same time securing and protecting the surgical instruments themselves from damage and facilitating a faster more accurate accounting of instruments and materials at all relevant times of a surgical operation. And, despite attempts in the art at improving surgical trays, there remains a need for an improved surgical tray that retains all the general/major/trauma instruments, arranges these instruments in a ready-to-use orientation, allows these instruments to be sterilized ahead of use, delivered to the operating room sterile, and minimizes set up time. Further, there remains a need for a system and method that standardizes safe and efficient operating procedures. Use of the disclosed surgical instrument tray in conjunction with the surgical back table using an imprinted mapped back table drape that provides for specific designated areas for specific surgical instruments and materials commonly present and used addresses this need. Also, there is a need for a standardized tray that readily, easily, quickly, economically, and efficiently adapts for various uses.